This is an interactive 2-day course which provides a fresh dynamic and offers attendees alternative approaches to problem solving. In addition, hands on exercises enable participants to map their individual GMP responsibilities and gain the skills and knowledge necessary to understand and work in a GMP compliant environment and contribute to the ongoing quality of their company and organization. Last year, Health Canada released revised guidelines to the GMP Regulations which became effective in October 2018. This course will include and cover these updates.
This 2-day course will cover the following topics:
- – Introduction and Definitions
- – Premises/building, Sanitation, Equipment and Personnel qualifications
- – Developing a pharmaceutical quality system
- – Raw material testing
- – Manufacturing & Production Controls
- – Finished product testing
- – Quality Control Department & Laboratory Controls
- – Packaging and Labelling Control
- – Retain Samples and Stability
- – Documentation, record keeping and Data Integrity
- – Health Canada GUI-0001 Good Manufacturing Practices for Drug Products
- – FDA part 211 Current Good Manufacturing Practice for Finished Products
Dr. Pauline McGregor, Ph.D. Chem, MRSC
Pauline has fulfilled a variety of roles in her thirty years in the pharmaceutical industry, including working with large Pharmaceutical corporations as well as contract testing laboratories in Canada and the UK. Pauline completed her honours degree and PhD in photo organic chemistry in Scotland, where she also taught analytical techniques to undergraduate students. On completing her PhD in 1995, she came to Canada to conclude her post doctoral studies at the University of Western Ontario.
Pauline has taught analytical R&D, method validation, GMP and related Quality Systems courses across Canada, in the USA, Jordan and China. Throughout her career, she has identified a lack of shared knowledge between Manufacturing, Quality Control, R & D and Quality Assurance sectors in the Healthcare Industries. She believes there is a need for cross education and training to allow the different disciplines to communicate with each other so that realistic objectives can be met by all in a timely manner with a harmonized understanding. Pauline is a member of The Royal Society of Chemistry, UK, is listed on the RSC Directory of Consultants. She is also on a USP Expert Committee for monograph review and on the USP Expert Panel for validation, verification and transfer of analytical procedures.
|Student Ticket:||$250.00||— Sold Out|
|Basic Member Ticket:||$1100.00||— Sold Out|
|Pro/Pro Plus Member Ticket:||$1025.00||— On Sale||Until: 15/11/19 11:55 PM|